NCT02719340

Brief Summary

Although long-segment posterior spinal fixation might provide more rigid fixation, the procedure increases perioperative morbidities in the elderly. The present study reviews the results of short-segment decompression and reconstruction in thoracolumbar fragile fractures.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

February 18, 2016

Last Update Submit

March 21, 2016

Conditions

Spinal Fractures

Outcome Measures

Primary Outcomes (1)

  • The Oswestry Disability Index (ODI)

    Functional outcome after surgery was evaluated using the Oswestry Disability Index (ODI)

    at least 2 years

Secondary Outcomes (3)

  • Frankel's grade system

    at least 2 years

  • Local kyphosis and vertebral wedge angle were measured as radiologic assessment (units of measure: degree)

    at least 2 years

  • anterior vertebral height

    at least 2 years

Interventions

short segment fixationPROCEDURE

posterior short-segment decompression and reconstruction (instrumentation on 1 level above and 1 level below the fractured vertebrae with posterolateral fusion)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Twenty elderly patients (60-89 years, mean 73.2 years) with osteoporotic thoracolumbar burst fractures and neurological compromise

You may qualify if:

  • osteoporotic burst fracture at a single level of the thoracolumbar region
  • dual-energy X-ray absorptiometry and T-score value less than -2.5

You may not qualify if:

  • translational displacement at the fracture site (fracture-dislocation)
  • loss of structural integrity within the posterior osteoligamentous complex (such as flexion-distraction ligament disruption)
  • spondylolisthesis of the adjacent vertebrae
  • malignancy
  • chronic steroid administration
  • previous spinal surgery
  • prior vertebroplasty and infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 25, 2016

Study Start

November 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2012

Last Updated

March 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share